To maintain precision when compiling design history files, manufacturers of Class 1 and Class II medical devices require the ability to build a comprehensive repository of all the design controls used in manufacturing their devices. MasterControl software, specifically tailored to meet manufacturers' DHF needs, is particularly useful in attaining and sustaining compliance with FDA, ISO, and CGMP regulations that are necessary for a device manufacturer's survival in business. Our design history files software solution is entirely Web-based, which allows authorized users from anywhere across the globe to remain connected in the entire document development lifecycle. MasterControl also allows for quick search and retrieval of documents so that they are readily available to respective stakeholders for reference. With the help of virtual folders called Explorers, manufacturers can keep data of each department separate yet accessible.

Various stakeholders (vendors, employees, auditors, etc.) can all collaborate together on DHF documents, checking them in and out of virtual vaults in a virtual workspace. As 21 CFR Part 11 emphasizes security practices that limit access to authorized users and holds them accountable for written policies, MasterControl ensures that electronic documents for design history files are stored in virtual vaults located in a central database for access by authorized users only. The system automatically locks both login and approval anytime either one is compromised.

Since the design of a device entails that many different types of documents will be produced, MasterControl design history files software allows users to develop and store documents irrespective of the software used for their production. To accommodate departmental needs and facilitate interactions across the enterprise, MasterControl's electronic document management system can also integrate DHF with other applications like ERP, LIMS, accounting, and human resources applications.

As a criterion of maintaining compliance, it is necessary that employees refer only to the latest set of documents. For this reason MasterControl design history files software provides a revision control feature to ensure that only the current version of DHF and standard operating procedure (SOP) documents are available.

MasterControl Design History Files (DHF) Software Automates Workflows

To manage intricate manufacturing procedures, it is important to manage a pre-defined workflow that routes documents from one department to another. The most efficient means of managing these workflows and task routing is automation. Automated design history files systems like MasterControl enable the routing, tracking, and escalation of tasks that are overdue for review or approval. Tasks can be made dependent on one another. Similarly, the automation of form-based processes enables manufacturers to eliminate errors that usually occur when entering the same information into different systems in various forms. The same design history files and form processes can also be integrated with forms from another department.

Another important feature of the software is its ability to maintain an accurate audit trail. As per CFR 21 Part 11 requirements, the system documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes that were made. in addition, the electronic sign-off feature enables manufacturers to keep track of document owners and collaborators when drafting, reviewing, and approving design history file documents. MasterControl design history files software can track DHF documents by status or history. A document will show as either in process or complete if tracked by status. The revision or approval history of electronic documents can also be reviewed using the history feature. Perhaps most importantly, MasterControl design history files software provides manufacturers with the capability of increasing management oversight. The reporting and advanced analytics features the software offers help management accurately evaluate the status of the company's design history files and make important business decisions.

For More Information on Design History Files

To learn more about electronic DHF management, document control and change management technical products, please contact a MasterControl representative.

The QMS Provider for the FDA

MasterControl Inc. and its partner company, i4DM, have been the QMS providers for the FDA’s Office of Regulatory Affairs (ORA) since 2009. The FDA recently expanded its implementation of MasterControl’s Quality Excellence™ solutions to improve the quality and audit management processes of the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER).